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FDA 510(k)

Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim

N.º K: K233405 · 2023-12-28

SolicitanteEco Medi Glove Sdn. Bhd.
Fecha de decisión2023-12-28
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim is the device name listed in this FDA 510(k) record. The listed applicant is Eco Medi Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2023-12-28 under 510(k) number K233405. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim?

Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim is a medical device that received FDA 510(k) clearance on 2023-12-28. The listed applicant is Eco Medi Glove Sdn. Bhd.. The 510(k) number is K233405.

When did Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim receive FDA 510(k) clearance?

Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim received FDA 510(k) clearance on 2023-12-28, under 510(k) number K233405.

Who is the listed applicant for Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim?

The FDA 510(k) record lists Eco Medi Glove Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim?

The FDA product code for Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim is LZA.

Ensayos clínicos relacionados

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Otros registros que enlistan a Eco Medi Glove Sdn. Bhd. como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K233560Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric AcidK232764Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK220943Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test ClaimK202401Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable ProteinK193121GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs ClaimsK181066Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims

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Dispositivos relacionados (Código: LZA)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealthK260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

Fuente oficial

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